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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062711
Other study ID # DMI 1484
Secondary ID
Status Completed
Phase N/A
First received February 3, 2010
Last updated July 19, 2011
Start date July 2008
Est. completion date May 2011

Study information

Verified date July 2011
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date May 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- Male

- Aged 60 to 80 years old

- Non-smoker

- Generally healthy and can tolerate the resistance exercise and protein drink

Exclusion Criteria:

- Allergies to whey, casein or soy

- Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study

- Failed clearance for exercise participation by their medical doctor

- Failed an exercise stress test

- Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic

- Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin

- Taking medications for lung and kidney conditions but excluding medication for asthma that is under control

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Whey or soy protein
Whey and casein are isolated milk proteins

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
McMaster University National Dairy Council

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle protein synthesis Acute within the day No
Primary whole body amino acid oxidation acute within the day No
Secondary muscle protein breakdown Acute within the day No
Secondary serum insulin acute within the day No
Secondary plasma amino acid concentrations acute within the day No
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